Cleared Special

Ambu aScope 4 RhinoLaryngo Slim

K191080 · Ambu A/S · Ear, Nose, Throat

May 2019

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K191080 is an FDA 510(k) clearance for the Ambu aScope 4 RhinoLaryngo Slim, a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Ambu A/S (Ballerup, DK). The FDA issued a Cleared decision on May 22, 2019, 28 days after receiving the submission on April 24, 2019. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K191080 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2019
Decision Date	May 22, 2019
Days to Decision	28 days
Submission Type	Special
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EOB — Nasopharyngoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4760
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).